Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two ...

Barad, chief digital and technology officer at HSS, outlined his approach to evaluating AI tools and how the orthopedic ...

The company plans to launch the device in Europe late next week, providing competition for AtriCure’s AtriClip product.

A 510(k) submission now planned for this quarter sets up a potentially faster clearance than the de novo pathway originally ...

The company has now treated 500,000 patients with its pulsed field ablation system, in a competitive category poised for ...

The clearance gives Distalmotion, which sees opportunity in ambulatory settings, a third robotic procedure category in the ...

Boston Scientific also foresees future growth in its Watchman business from a planned label expansion and concomitant ...

The medical device industry has a jam-packed year of events for professionals to attend, including the J.P. Morgan Healthcare ...

The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.

After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially ...

The number of medtech funding rounds has declined in recent months, but the value of overall deals has increased, according ...

The Essilor Stellest eyeglass lenses are designed to slow myopia progression in children. The lenses have a clear 9mm ...